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510(k) Data Aggregation
(42 days)
Medeor Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to; defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; hernia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications; and for reinforcement of the soft tissues, which are repaired by suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.
The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.
The device is intended for single use only.
The purpose of this submission is to add hydration with autologous bodily fluids to the labeling of the Medeor Matrix device. Medeor Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues where weakness exists. The device is supplied sterile in double-layer peel-open packages. The device is packaged either dry or hydrated with saline. The device can be hydrated with saline or autologous bodily fluids prior to implantation.
Acceptance Criteria and Device Performance Study
This document describes the acceptance criteria and the study that demonstrates the Medeor™ Matrix device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Must meet requirements of ISO 10993-1:2003 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis). | The Medeor Matrix surgical mesh passed the requirements of all tests conducted according to ISO 10993-1:2003, including: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity and Hemolysis. |
| Viral Inactivation | Appropriate levels of viral inactivation. | Manufacturing methods were tested by an independent laboratory to assure appropriate levels of viral inactivation. |
| Mechanical Testing | Not explicitly stated in the provided text, but implied to be sufficient for soft tissue reinforcement. | Mechanical test reports were completed for: - Tensile Testing - Suture Retention. The device passed the requirements of all tests. |
| Hydration Testing | Not explicitly stated, but implied to allow for hydration with various fluids. | Hydration testing was performed using various hydration fluids. The device passed the requirements of all tests. |
| In Vivo Performance | Not explicitly stated, but implied to demonstrate appropriate tissue repair and reaction in animal models. | The device was evaluated in two in vivo studies: - Defects were repaired and evaluated in a sheep model. - A rabbit study was performed to evaluate tissue reactions. The device passed the requirements of all tests. |
| Substantial Equivalence | Demonstrated equivalence to predicate devices (Medeor™ Matrix (K091499) and KN ECM Surgical Patch (K094061)) in materials, intended use, and technological characteristics. | Performance Testing confirmed that Medeor Matrix is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify exact sample sizes for each test within the performance data section. However, it indicates the following studies were conducted:
- Biocompatibility Tests: The tests were conducted "on the finished device," implying a sufficient number of samples for each specific test mandated by ISO 10993-1:2003.
- Mechanical Tests (Tensile Testing, Suture Retention): Samples of the Medeor™ Matrix were used for these tests.
- Hydration Testing: Samples were tested with "various hydration fluids."
- In Vivo Studies:
- Sheep Model: Defects were repaired and evaluated in a sheep model. The specific number of sheep is not provided.
- Rabbit Study: A rabbit study was performed to evaluate tissue reactions. The specific number of rabbits is not provided.
Data Provenance:
The data was generated through laboratory testing and animal studies. The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, implying the data would be acceptable to U.S. regulatory standards. All studies appear to be prospective in nature, as they were specifically conducted to evaluate the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set in the context of human interpretation or review. The evaluation of the device relied on standardized laboratory tests (biocompatibility, mechanical, hydration) and animal models (in vivo studies). The "ground truth" for these tests would be the established scientific and engineering principles, and the interpretation of results would be by qualified laboratory personnel and researchers, rather than a panel of clinical experts adjudicating cases.
4. Adjudication Method for the Test Set
Not applicable. The reported studies (biocompatibility, mechanical, in vivo) are objective tests with predefined pass/fail criteria based on scientific standards and observations, not on expert consensus or adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This type of study typically involves human readers evaluating medical images or data, with and without AI assistance, to measure improvements in diagnostic accuracy or efficiency. The Medeor™ Matrix is a surgical mesh, not an AI-powered diagnostic device, so such a study would not be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not conducted. The Medeor™ Matrix is a physical medical device, not a software algorithm. Therefore, "algorithm only" performance is not applicable.
7. Type of Ground Truth Used
The ground truth for the various tests was based on:
- Established Industry Standards: For biocompatibility, adherence to ISO 10993-1:2003.
- Inherent Material Properties: For mechanical testing (tensile strength, suture retention) and hydration properties, the measurements are objective.
- Biological Response: For viral inactivation and in vivo studies (sheep model for repair, rabbit study for tissue reactions), the ground truth was the observable biological outcomes and whether they met safety and performance expectations.
8. Sample Size for the Training Set
Not applicable. The Medeor™ Matrix is a physical surgical mesh and not an AI/machine learning model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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(193 days)
The Kensey Nash P1076 Collagen Dental Membrane is indicated for:
- Simultaneous use of GBR-membrane and implants.
- Augmentation around implants placed in immediate extraction sites.
- Augmentation around implants placed in delayed extraction sockets.
- Localized ridge augmentation for later implantation.
- Alveolar ridge reconstruction for prosthetic treatment.
- Filling of bone defects after root resection, cystectomy, removal of retained teeth.
- Guided bone regeneration in dehiscence defects.
- Guided tissue regeneration procedures in periodontal defects
The Kensey Nash (KN) P1076 Collagen Dental Membrane is a translucent, resorbable, rectangular collagen membrane sheet derived from bovine tissue. The KN P1076 Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.
The provided text is a 510(k) summary for the Kensey Nash P1076 Collagen Dental Membrane, a medical device submission to the FDA. It does not contain any information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, or study methodologies typically associated with proving a device meets specific performance criteria.
The document primarily focuses on:
- Device Description: What the Kensey Nash P1076 Collagen Dental Membrane is (translucent, resorbable, rectangular collagen membrane sheet from bovine tissue, single-use, sterilized by Ethylene Oxide).
- Intended Use/Indications For Use: The specific dental procedures for which the membrane is intended (e.g., GBR with implants, augmentation around implants, localized ridge augmentation, filling bone defects, guided bone and tissue regeneration).
- Predicate Devices: Kensey Nash compares its device to Geistlich Pharma AG's Bio-Gide (K050466) and Collagen Matrix, Inc.'s Collagen Dental Membrane - Conformable II (K062881).
- Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. The document states: "Performance Testing has confirmed that the Kensey Nash P1076 Collagen Dental Membrane is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k)."
Key Missing Information:
The document claims that "Performance Testing has confirmed...substantial equivalence" but does not provide any details about this performance testing. Therefore, I cannot extract the information required to answer your prompt, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance for a test set.
- Number/qualifications of experts, adjudication methods for ground truth.
- Results of any Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
- Type of ground truth used.
- Sample size for training set or how its ground truth was established.
Conclusion:
Based solely on the provided text, it is impossible to describe the acceptance criteria and the study that proves the device meets them because these specifics are not detailed in the 510(k) summary provided. The summary asserts that performance testing was done to demonstrate substantial equivalence, but it does not present the results or methodology of that testing.
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(154 days)
Medeor™ Matrix is indicated for use in general surgical procedures for the reinforcement and repair of soft tissue where weakness exists including, but not limited to: defects of the thoracic wall, suture line reinforcement, and muscle flap reinforcement; urogynecological reinforcement (excluding transvaginal repair of pelvic organ prolaps) including but not limited to, rectal prolapse (excluding rectocele) using an abdominal approach, vaginal prolapse (excluding transvaginal repair of pelvic organ prolapse), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), hemia repair; soft tissue reconstructive procedures including plastic and reconstructive surgical applications, and for reinforcement of the soft tissues, which are repaired by suture or suture anchors, including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons.
Medeor Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the bone, provide biomechanical strength for the tendon repair.
Medeor Matrix is intended for one time use.
Medeor™ Matrix is a resorbable porcine-derived collagen surgical mesh intended for reinforcement of soft tissues. The device is supplied sterile in double-layer peel-open packages. The product is either packaged dry (lyophilized) to be hydrated prior to use, or can be supplied prehydrated, packaged and sterilized in saline.
This document describes the performance data for the Medeor Matrix, a surgical mesh, in support of its 510(k) submission. However, it does not describe an AI/ML device or studies typically associated with such devices (e.g., comparative effectiveness studies with human readers, standalone algorithm performance, or ground truth establishment relevant to AI models). Therefore, I cannot extract information related to AI/ML device performance or study design for an AI/ML model from this document.
The document focuses on the traditional regulatory submission requirements for a medical device (surgical mesh), including mechanical testing and biocompatibility studies.
Let's break down what is available in the document regarding its performance criteria and studies for the Medeor Matrix surgical mesh:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a formal table of acceptance criteria with numerical targets. Instead, it states that the device "passed the requirements of all tests" for biocompatibility and "demonstrated equivalence of the device to legally cleared predicate devices" for mechanical testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing | Demonstrated equivalence to legally cleared predicate devices for Tensile Testing and Suture Retention. |
| Biocompatibility Testing | Passed the requirements of all tests conducted per ISO 10993-1:2003, including Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity, Implantation, Pyrogenicity, and Hemolysis. |
| In Vivo Studies | Results not explicitly detailed as "acceptance criteria met," but implies successful outcomes for defect repair in a sheep model and tissue reactions in a rabbit study. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Mechanical Testing: Sample sizes are not specified for Tensile Testing and Suture Retention.
- Biocompatibility Testing: Sample sizes are not specified.
- In Vivo Studies:
- Sheep model: "defects were repaired and evaluated in a sheep model." Sample size not specified.
- Rabbit study: "a rabbit study was performed to evaluate tissue reactions." Sample size not specified.
- Data Provenance: Not specified within the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as this document describes a physical medical device (surgical mesh) and its performance, not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this document describes a physical medical device (surgical mesh) and its performance, not an AI/ML device adjudicated by experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. No MRMC study was conducted as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI/ML device; therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" would be the measured physical properties and their comparison to established standards or predicate devices. For biocompatibility, it's adherence to ISO 10993 standards and accepted biological response criteria. For in vivo studies, the "ground truth" would be histological analysis, gross observations, and clinical outcomes in the animal models.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device.
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(184 days)
The Kensey Nash Fibrillar Collagen Dental Membrane is indicated for:
- . Simultaneous use of Guided Bone Regeneration (GBR)-membrane and implants.
- Augmentation around implants placed in immediate extraction sites. .
- . Augmentation around implants placed in delayed extraction sockets.
- Localized ridge augmentation for later implantation. .
- . Alveolar ridge reconstruction for prosthetic treatment.
- Filling of bone defects after root resection, cystectomy, removal of retained teeth. .
- Guided bone regeneration in dehiscence defects. .
- . Guided tissue regeneration procedures in periodontal defects
The Kensey Nash (KN) Fibrillar Collagen Dental Membrane is a translucent, resorbable, non-friable, rectangular collagen membrane sheet derived from bovine tissue. The KN Fibrillar Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.
The provided text is a 510(k) summary for the Kensey Nash Fibrillar Collagen Dental Membrane. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about specific acceptance criteria or a study demonstrating the device meets those criteria.
The document states: "Performance Testing has confirmed that the Kensey Nash Fibrillar Collagen Dental Membrane is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k)." This is a general statement and does not provide details of acceptance criteria or performance results.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details because this information is not present in the provided text.
The closest information provided is the list of predicate devices, implying that the new device's performance is compared to theirs for substantial equivalence, but the specific metrics and comparison results are absent.
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(105 days)
The OuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
The QuickCat™ Extraction Catheter is a single use, disposable, dual lumen catheter with associated accessories consisting of a 30 ml. vacuum syringe, extension tubing with stopcock, and an independent 40-micron filter basket. The 145 cm working length and is compatible with 6F guiding catheters with an inner diameter (I.D.) > 0.068" (1.73 mm) and 0.014" (0.36 mm) diameter guidewires. The extraction lumen of the catheter facilitates removal of emboli and thrombi via the attached tubing assembly, stopcock and vacuum syringe. The atraumatic distal tip, which incorporates a radiopaque marker for visibility under fluoroscopy, provides for smooth passage in the arterial system. The catheter consists of three segments. The stiffer proximal segment and more flexible distal segments provide the required structural integrity and flexibility to navigate tortuous vasculature. The distal segment consists of a dual lumen to allow for "rapid exchange" attachment to the guidewire. The catheter's distal portion has a hydrophilic coating to enhance deliverability. A 40-micron pore filter basket is supplied to assist in filtering of blood and thrombotic material for visual or laboratory analysis.
I am sorry, but based on the provided document, there is no acceptance criteria or a study described that proves the device meets specific performance criteria in the way you've outlined.
This document is a 510(k) premarket notification approval letter for the QuickCat Extraction Catheter. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed clinical or statistical studies as would be required for a novel device or a PMA submission.
Here's a breakdown of why the requested information cannot be extracted from this document:
-
Table of acceptance criteria and reported device performance: This document does not contain any specific performance metrics (e.g., sensitivity, specificity, accuracy, success rates) or acceptance criteria for those metrics. The "Non-Clinical Summary" merely states that "Results of this testing indicate that the QuickCat design meets all specifications and intended use," which is a general statement and not a table of specific criteria and results.
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Sample size used for the test set and data provenance: No information is provided about a "test set" in the context of performance evaluation. The document mentions "in-vitro bench testing and biocompatibility testing" but does not give details about the sample sizes or the origin of any data used in these tests.
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Number of experts and qualifications for ground truth: Since there are no specific performance claims or clinical study results beyond the general statement of meeting specifications, there's no mention of experts establishing ground truth for a test set.
-
Adjudication method for the test set: Not applicable, as no information on a test set or expert evaluation is provided.
-
Multi-reader multi-case (MRMC) comparative effectiveness study: This document does not describe any MRMC study, nor does it refer to AI assistance. The device is a physical catheter, not an AI-powered diagnostic tool.
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Standalone performance (algorithm only): Not applicable. The device is a physical medical device, not an algorithm.
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Type of ground truth used: Not applicable, as detailed performance studies generating ground truth are not described. The basis for substantial equivalence is primarily the comparison of technological characteristics and intended use to a predicate device, along with verification through bench and biocompatibility testing.
-
Sample size for the training set: Not applicable. The device is not an AI algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable for the same reason as above.
In summary, the provided FDA 510(k) approval letter (K073519) for the QuickCat Extraction Catheter focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting detailed performance acceptance criteria and study results in the manner requested for AI/software-as-a-medical-device (SaMD) products.
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(194 days)
The Kensey Nash Bioresorbable Surgical Mesh is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Tissue attachment to the bioresorbable surgical mesh is minimized in case of direct contact with the viscera.
The Kensey Nash Bioresorbable Mesh is a biodegradable surgical mesh for trauma and reconstructive surgical procedures involving soft tissues. The Kensey Nash Bioresorbable Mesh is available in various sizes and thickness for use in maintaining the relative position of healing tissues. The implants maintain the stability of soft tissues during the healing period and minimize the attachment of the device. The Kensey Nash Bioresorbable Mesh material is subsequently reabsorbed by the body once the soft tissues have healed. The implants are not intended for use where permanent implants are required.
This document is a 510(k) premarket notification for a medical device called the "Kensey Nash Bioresorbable Surgical Mesh". It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a PMA (Premarket Approval) application.
Medical devices cleared through the 510(k) pathway do not typically involve the type of acceptance criteria and clinical study designs seen in AI/software as a medical device (SaMD) or drug approval processes. Instead, the focus is on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use and technological characteristics as a legally marketed device, or, if there are differences, that those differences do not raise different questions of safety and effectiveness.
Therefore, the requested information (acceptance criteria, specific study details like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is generally not applicable to a 510(k) submission for a physical medical device like a surgical mesh. These questions are more relevant to performance studies for diagnostic devices, AI algorithms, or clinical trials for drug products.
However, I can extract information related to the demonstration of "substantial equivalence" as it functions similarly to meeting "acceptance criteria" for physical devices. The "study" in this context is the comparison to predicate devices, supported by in vitro and in vivo testing.
Here's an attempt to adapt your request to the provided document, focusing on "substantial equivalence" as the "acceptance criteria":
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
The "acceptance criteria" for the Kensey Nash Bioresorbable Surgical Mesh are met by demonstrating substantial equivalence to legally marketed predicate devices. This demonstration involves showing that the new device has the same intended use and substantially equivalent technological characteristics (design, materials, mechanical performance) to the predicates, and that any differences do not raise new questions of safety or effectiveness.
The "study" proving this substantial equivalence primarily involved comparative analysis with predicate devices, supported by in vitro and in vivo testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as demonstrated in the submission) |
|---|---|
| Intended Use: Identical to predicate devices. | The Kensey Nash Bioresorbable Surgical Mesh shares identical indications for use principles with the predicate devices (MacroPore Surgi-Wrap (TS) and MacroPore Surgi-Wrap MAST). Both are indicated for temporary wound support, reinforcing soft tissues, and repair of hernia/fascial defects, minimizing tissue attachment to viscera. |
| Design Principles: Substantially equivalent to predicates. | Physical designs are substantially equivalent, consisting of thin, semi-rigid, bioresorbable sheets manufactured by the same process. Both allow for contouring when heated (e.g., Kensey Nash device and Surgi-Wrap predicate are fully contourable at ~55°C). |
| Materials: Identical or substantially equivalent. | Made from the identical bioresorbable PLA raw material: amorphous biodegradable copolymer 70:30 poly (L-lactide-co, DL-lactide). |
| Physical Characteristics (Thickness, Shapes, Sizes): Substantially equivalent to predicates. | Thickness: Thinnest device (0.02mm) is identical to the Surgi-Wrap predicate. Sizes: Rectangular sheets ranging from 25mm x 25mm to 500mm, with thickness ranges from 0.02mm to 1.0mm, substantially equivalent to predicates. Both can be cut to specific shapes/sizes by the end user. |
| Mechanical Characteristics: Substantially equivalent. | Mechanical characteristics are substantially equivalent to the predicate devices with respect to mechanical strength. (Specific quantitative comparisons are not detailed in this excerpt but are implied to be part of the full submission). In vitro testing showed inherent viscosity remained appropriate when heated. Aging and mechanical testing for adequacy for indications. |
| Safety and Efficacy: Demonstrated via testing. | In Vitro Testing: Confirmed material integrity and stability when heated (relevant for surgical preparation). Aging and mechanical testing supported adequacy for indications. In Vivo Testing: Animal studies shown to demonstrate the device material is safe and efficacious for the indications for use. |
| Biocompatibility/Resorption: Consistent with predicates. | Material degrades and resorbs in vivo by hydrolysis and is metabolized by the body into CO2 and H3O, consistent with the known behavior of the identical raw material also used in predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- In Vitro Testing: The document mentions "Testing has shown inherent viscosity remains within an appropriate range over 120 minutes when heated to 60°C in saline" and "Aging and mechanical testing shows that the device material is adequate."
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified; likely internal lab testing by Kensey Nash Corporation.
- Retrospective/Prospective: These are typically controlled, prospective laboratory studies.
- In Vivo Testing: The document states "The animal studies have shown that the device material is safe and efficacious for the indications for use."
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified; generally conducted in research institutions or CROs, often within the US or compliant with international standards.
- Retrospective/Prospective: These are typically prospective animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable in the context of this 510(k) submission for a physical surgical mesh. This type of expert ground truth establishment is primarily for diagnostic devices or AI algorithms. The assessment of substantial equivalence relies on engineering and biological comparative analysis, and animal study results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for subjective assessments, especially in clinical trials or for diagnostic image interpretation. The tests conducted here (inherent viscosity, mechanical testing, animal studies) rely on objective measurements and observations, which do not require interpretive adjudication in the same manner.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. MRMC studies are for evaluating the performance of diagnostic imaging devices or AI tools, often involving human readers interpreting cases. This device is a surgical implant, not an imaging or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical mesh, not an algorithm or software. Its performance is inherent to its material properties and design, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the comparative analysis to predicate devices, the "ground truth" for substantial equivalence is derived from:
- Predicate Device Specifications: The established indications, design, materials, and mechanical properties of the legally marketed predicate devices (MacroPore Surgi-Wrap and MacroPore Surgi-Wrap MAST).
- Objective Measurements: Results from in vitro (e.g., inherent viscosity, mechanical strength) and in vivo (e.g., safety, efficacy, tissue response in animal models) testing of the Kensey Nash Bioresorbable Surgical Mesh, which are then compared to the expected performance of or actual data from the predicate devices (if available/required for comparison).
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for a physical medical device.
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(28 days)
CopiOs® Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis and spine, i.e., posterolateral spine fusion procedures with appropriate stabilizing hardware) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.
CopiOs® Bone Void Fillers are resorbable sponges or paste (hydrated powder discs), which are manufactured from calcium phosphate and Type I bovine dermal collagen. CopiOs® devices are gamma-sterilized for single use and supplied in 1cc. 5cc and 10cc volumes.
The provided text is a 510(k) summary for the CopiOs® Bone Void Filler. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria as might be seen for a new drug or a novel device with a very different mechanism of action.
Therefore, the document does not contain information about:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the submission states:
Acceptance Criteria/Study Information:
-
Substantial Equivalence: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. The document explicitly states:
- "CopiOs® Bone Void Filler Sponge & Paste is substantially equivalent to the legally marketed predicate device, CopiOs® Bone Void Filler Sponge & Paste (K071237) having identical device designs, materials, processing, intended use and fundamental scientific technology."
- The predicate devices mentioned are K071237 (CopiOs Bone Void Filler Sponge & Paste) and K033679 (CopiOs™ Bone Void Filler).
-
Non-Clinical Testing:
- The document mentions that "CopiOs® Bone Void Filler Sponge & Paste have previously undergone non-clinical testing, including animal study, biocompatibility, migration resistance, pH, hydration and handling characteristics."
- This testing "provides reasonable assurance of safety and effectiveness for its intended use."
In summary, the 510(k) process for this device did not involve the types of studies typically associated with "acceptance criteria" for performance metrics in the way a diagnostic algorithm or a novel therapeutic might. Instead, the focus was on demonstrating that the new device is as safe and effective as a previously cleared device through substantial equivalence and supporting non-clinical data.
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(16 days)
ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae.
ThromCat™ Thrombectomy Catheter System is a single-use, disposable device that performs percutaneous maceration and removal of thrombus and restoration of blood flow. The device consists of a 5.5 Fr infusion/extraction catheter, a DC-powered infusion/extraction pump, and an extraction line and bag. The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft, preventing direct contact with the vessel wall. The integrated pumps, tubing, and 150cm length catheter provide an infusion flow to "wash" the vessel, while simultaneously providing an extraction flow to remove thrombus.
The provided document is a 510(k) summary for the ThromCat™ Thrombectomy Catheter System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain a study that proves the device meets specific acceptance criteria.
The "Non-Clinical Summary" section states: "Non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing. Results of this testing indicate that the ThromCat design meets all specifications and intended use." This is a general statement, but no specific acceptance criteria or detailed study results are provided.
Therefore, I cannot fulfill all parts of your request as the necessary information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing" and that "results of this testing indicate that the ThromCat design meets all specifications and intended use." However, it does not provide any specific acceptance criteria (e.g., "thrombus removal efficiency > 90%") or reported device performance metrics tied to those criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document only mentions "in-vitro bench testing" and "biocompatibility testing" but does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Cannot be provided. Since the studies mentioned are "in-vitro bench testing" and "biocompatibility testing," they are likely physical or chemical tests that do not involve human expert interpretation for establishing ground truth in the way a clinical image analysis study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided. As above, this is not relevant for the type of bench and biocompatibility testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The document does not describe any MRMC comparative effectiveness study, nor does it involve AI assistance. This device is a physical thrombectomy catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided definitively for "in-vitro bench testing." For "biocompatibility testing," the ground truth would typically be established by standardized toxicological and immunological assays against established safety limits or comparison to predicate device materials, rather than expert consensus on medical images or pathology.
8. The sample size for the training set
- Not applicable. This device is a physical medical device, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, this is not relevant for a physical medical device.
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(29 days)
CopiOs™ Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.
CopiOs™ Bone Void Fillers are resorbable rectangular sponges or powder discs manufactured from calcium phosphate and Type I bovine dermal collagen. CopiOsTM Paste, a compressed powder disc, forms a paste when mixed with autologous blood products using the supplied spatula. CopiOs™ devices are gamma-sterilized for single use and supplied in 1cc, 5cc and 10cc volumes.
The provided 510(k) summary for K071237, CopiOs™ Bone Void Filler, does not contain detailed acceptance criteria or a comprehensive study report with the requested information. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No explicit criteria mentioned, but assumed to meet ISO 10993 standards for medical devices. | "CopiOs™ Paste has undergone non-clinical testing, including biocompatibility..." |
| Migration Resistance | No explicit criteria mentioned. | "non-clinical testing, including... migration resistance" |
| pH | No explicit criteria mentioned. | "non-clinical testing, including... pH" |
| Hydration Characteristics | No explicit criteria mentioned. | "non-clinical testing, including... hydration" |
| Handling Characteristics | No explicit criteria mentioned, but likely relates to ease of mixing and packing. | "non-clinical testing, including... handling characteristics" |
| Safety and Effectiveness | Reasonable assurance of safety and effectiveness for intended use, as per substantial equivalence. | "Testing provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate device." |
Missing Information:
- Specific numerical or qualitative targets for each acceptance criterion (e.g., pH range, migration limits, specific mechanical properties related to handling).
- Quantitative results or detailed qualitative descriptions of the device's performance against these criteria. The document only lists the types of tests performed, not the results.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "non-clinical testing" was performed but does not provide details on the number of samples used for each test (e.g., number of specimens for biocompatibility, number of paste samples for pH testing).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Non-clinical testing typically refers to laboratory-based evaluations, so it wouldn't be retrospective/prospective in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided. This device is not an AI/diagnostic device that would require expert-established ground truth for a test set. The non-clinical testing for this bone void filler would involve laboratory analyses and physical/chemical characterization, not expert interpretation of results in the way a diagnostic algorithm does.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC study was not done. This device is a medical implant (bone void filler), not a diagnostic imaging or AI-assisted system that would typically undergo an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- No, a standalone performance study was not done. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- This information is not applicable in the typical sense of AI/diagnostic devices. For non-clinical testing, "ground truth" would be established by validated analytical methods (e.g., pH meter readings, material composition analysis, cell culture assays for biocompatibility). The document does not specify the methods or "ground truth" for individual tests.
8. The Sample Size for the Training Set
- This information is not applicable. This device is a physical medical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the same reason as point 8.
Summary of Device and Evidence:
The Kensey Nash Corporation's CopiOs™ Bone Void Filler (K071237) is a resorbable bone void filler made from calcium phosphate and Type I bovine dermal collagen, intended to fill bone voids in the skeletal system.
The company demonstrated substantial equivalence to its predicate device (K033679 - CopiOs™ Bone Void Filler (Sponge)) rather than conducting a standalone clinical effectiveness study with defined acceptance criteria for clinical outcomes. The justification for substantial equivalence relies on:
- Non-Clinical Testing: The submission states that CopiOs™ Paste underwent non-clinical testing for:
- Biocompatibility
- Migration resistance
- pH
- Hydration characteristics
- Handling characteristics
- Conclusion: This testing "provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate device." The submission emphasizes that the new device (CopiOs™ Paste) is "substantially equivalent to the legally marketed predicate device, CopiOs™ Sponge with regard to materials, processing, intended use and fundamental scientific technology."
The provided documentation does not include specific, quantitative acceptance criteria or detailed results from the non-clinical tests. Instead, it relies on the broader concept of substantial equivalence, asserting that the new device performs comparably to a previously cleared predicate device, and the non-clinical tests confirmed its safety and basic functional properties.
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(25 days)
The TriActiv FX® Embolic Protection System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.0m in diameter. The TriActiv FX® Embolic Protection System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI.
The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.
The TriActiv FX® Embolic Protection System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal components: ShieldWire™ Balloon Guidewire ("balloon guidewire), ShieldWire™ Inflator ("inflator"), FX™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also four subcomponents or accessories included in the TriActiv FX® Embolic Protection the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, System: TriActiv® Flow Control Power Supply and TriActiv® Tuohy. All TriActiv FX® Embolic Protection System components are supplied sterile and for single use only with exception of the TriActiv® Flow Control Power Supply which is non-sterile and reusable.
The balloon guidewire is advanced through the hospital-supplied 7F guide catheter (without sideholes) prior to percutaneous coronary intervention of a saphenous vein araft (SVG) and positioned just past the target lesion. The balloon is inflated with a medical grade carbon dioxide gas blend, creating a protected space between the quide catheter and the balloon. Once the balloon is inflated and vessel occlusion is confirmed, PTCA and/or stenting can be performed over the balloon guidewire. Immediately after intervention, the flush catheter is loaded on the balloon guidewire and advanced into the graft. With the flush catheter positioned just proximal to the balloon, the flow control delivers saline through the flush catheter to gently wash the vessel and remove any debris generated during the intervention through the guide catheter into a collection bag. The TriActiv FX® Embolic Protection System has been designed to extract at a greater rate than it infuses to prevent aortic embolization. Once the physician is satisfied with the amount of debris removed from the vessel, the protection balloon is deflated and the device is removed.
Here's a breakdown of the acceptance criteria and the study details for the TriActiv FX® Embolic Protection System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TriActiv FX® Embolic Protection System were primarily established through a non-inferiority comparison to existing predicate devices (Medtronic Guardwire® or Boston Scientific Filterwire EX™). The key performance metrics are related to Major Adverse Cardiac Events (MACE) and other clinical outcomes.
| Metric (Acceptance Criteria) | Reported Device Performance (TriActiv FX® - ASPIRE Study) | Reference Device Performance (Guardwire® / Filterwire EX™ - PRIDE Study) | Adjusted P-Value | Unadjusted Difference (95% CI) |
|---|---|---|---|---|
| MACE to 30 days (Non-inferiority to predicate) | 3.2% (3/93) | 10.1% (32/318) | 0.013 | -6.8% (-2.7%) |
| Myocardial Infarction (MI) (Lower rate desired) | 2.2% (2/93) | 8.8% (28/318) | 0.021 | -6.7% (-3.1%) |
| Device Success⁴ | 95.7% (89/93) | 94.5% (293/310) | 0.79 | 1.2% (-2.9%) |
| Procedure Success/Patient⁵ (Criteria for successful procedure) | 97.8% (90/92) | 90.5% (286/316) | 0.013 | 7.3% (3.6%) |
| Lesion Success/Lesion⁶ (Criteria for successful lesion treatment) | 100% (103/103) | 99.4% (319/321) | - | 0.6% (-0.1%) |
| Final TIMI Flow 0 | 0% (0/97) | 0.6% (2/306) | 0.98 | - |
| Final TIMI Flow 1 | 0% (0/97) | 0.6% (2/306) | - | - |
| Final TIMI Flow 2 | 4.1% (4/97) | 0.9% (3/306) | - | - |
⁴ Device success is defined as attainment of all of the following: the device was successfully delivered to the target location, the device operated as intended, the device was successfully retrieved.
⁵ Final stenosis < 50% by QCA for all lesions and no in-hospital MACE.
⁶ Final stenosis < 50% by QCA.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set):
- TriActiv FX® (ASPIRE Study): 93 patients in the Enrollment Phase (113 total patients enrolled, 20 were "roll-in" patients for training).
- Control (PRIDE Study Active Control): 318 patients.
- Data Provenance:
- Country of Origin: The ASPIRE Study was conducted at 17 U.S. and 3 German investigational sites. The PRIDE Study data is referred to as "historical control data" and is implied to be from a similar multi-center, potentially international, context given the device manufacturers.
- Retrospective or Prospective:
- ASPIRE Study: Prospective, multi-center, non-randomized.
- PRIDE Study Active Control: Retrospective (used as historical control data). The PRIDE study itself was likely prospective, but the data was utilized retrospectively for comparison in this 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. The outcomes (e.g., MACE, MI) are clinical endpoints based on patient diagnosis and objective measurements, likely adjudicated by physicians involved in the studies, but specific details on an adjudication committee or expert panel for ground truth are not provided in this summary.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set (e.g., 2+1, 3+1). Clinical events like MACE and MI are typically adjudicated by an independent clinical events committee in large trials, but this specific detail is not present in the summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an embolic protection system, a physical medical device, not an AI or imaging diagnostic tool that would typically involve "human readers" or "AI assistance." The study evaluates the device's clinical performance in preventing adverse events during a procedure.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's performance was based on clinical outcomes data. Specifically, it included:
- Major Adverse Cardiac Events (MACE)
- Death (Cardiac, Non-Cardiac)
- Myocardial Infarction (MI) (Q wave, Non-Q wave)
- Target Vessel Revascularization (TVR)
- Stroke
- Hemorrhagic/vascular complications
- Transfusion
- Device Success (defined by successful delivery, operation, and retrieval)
- Procedure Success/Patient (defined by final stenosis < 50% by QCA and no in-hospital MACE)
- Lesion Success/Lesion (defined by final stenosis < 50% by QCA)
- Final TIMI Flow
These are direct clinical endpoints and objective measurements taken during and after the intervention.
8. The Sample Size for the Training Set
The document refers to "roll-in" patients for training purposes within the ASPIRE study:
- Training Set Size: 20 patients (out of 113 total enrolled in ASPIRE). These were for "training purposes" for the investigators, not for training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
For the 20 "roll-in" patients, the ground truth was established through standard clinical evaluation and reporting of outcomes, similar to the main study patients. However, their data was likely not included in the primary efficacy analysis for statistical rigor, as their purpose was for investigator training/familiarization with the device. This "training" refers to human operators learning to use the device, not a machine learning model.
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